QKM — A Chemical Vapor Sterilization Multivariable Chemical Indicator Class II
Classification Details
- Product Code
- QKM
- Device Class
- Class II
- Regulation Number
- 880.2800
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232103 | terragene | Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® | April 5, 2024 |
| K212022 | 3m | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | April 20, 2022 |
| K213262 | steris corporation | CELERITY HP Chemical Indicator | January 7, 2022 |
| K203284 | 3m | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator | December 7, 2020 |
| K193110 | 3m healthcare | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | March 13, 2020 |